FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GELLHORN PESSARY 33410 VARIOUS SIZES
K Number: K890565
·
Decision Mar 29, 1989
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
40
Applicant Total
4
Review Days
51
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Basic Information
- Device Name
- GELLHORN PESSARY 33410 VARIOUS SIZES
- K Number
- K890565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.3575
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Source, Inc.
- Date Received
- February 6, 1989
- Decision Date
- March 29, 1989
- Product Code
- HHW
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HHW | Pessary, Vaginal | FDA class 2 | Obstetrics/Gynecology |
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